Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops) Recalled by Hill Dermaceuticals, Inc. Due to Subpotent Drug: The active ingredient, fluocinolone acetonide, was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hill Dermaceuticals, Inc. directly.
Affected Products
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
Quantity: 13,379 bottles
Why Was This Recalled?
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hill Dermaceuticals, Inc.
Hill Dermaceuticals, Inc. has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report